BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 13667082 · Received March 4, 2022

    Report

    Report Number
    3007009755-2022-00001
    Event Type
    Injury
    Date Received
    March 4, 2022
    Report Date
    April 11, 2022
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: SINCLAIR ARE FOLLOWING UP FOR THE LOT NUMBER OF THE PRODUCT USED. THE EVENT IS NOT INDICATIVE OF A PRODUCT OR BATCH RELATED ISSUE. OTHER COMMENT: SINCLAIR ARE FOLLOWING UP FOR FURTHER INFORMATION REGARDING THE EVENT AND FURTHER DETAILS WILL BE PROVIDED WITHIN A FOLLOW UP REPORT. SINCLAIR ARE REPORTING THIS EVENT DUE TO THE APPARENT SURGICAL INTERVENTION THAT THE PATIENT HAS UNDERGONE FOLLOWING SILHOUETTE INSTALIFT TREATMENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: A BATCH NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH INVESTIGATION COULD NOT BE CONDUCTED. THERE IS NO INDICATION OF A PRODUCT DEFECT NOR A BATCH RELATED ISSUE. CLINICAL COMMENT: THE PATIENT REPORTED HAVING UNDERGONE SIX SURGERIES AND THAT FOLLOWING ASSESSMENT BY PHYSICIANS, THEY ARE OF THE OPINION THAT THE PATIENT HAD NOT EXPERIENCED AN INFECTION. DESPITE REQUESTS, NO FURTHER DETAILS OR CLINICAL REPORTS WERE RECEIVED. OTHER COMMENT: LIMITED INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT'S EVENT AND FROM THE AVAILABLE INFORMATION, THE PATIENT APPEARS TO HAVE EXPERIENCED AN INFLAMMATORY REACTION. THE SILHOUETTE INSTALIFT INSTRUCTIONS FOR USE (IFU) LISTS INFLAMMATORY TISSUE REACTION AS A POTENTIAL ADVERSE REACTION THAT CAN OCCUR POST TREATMENT. IT IS UNDERSTOOD THAT PHYSICIANS WHO HAVE REVIEWED THE PATIENT ARE OF THE OPINION THAT THEY HAD NOT EXPERIENCED AN INFECTION. (NO FURTHER DETAILS RECEIVED). THE SILHOUETTE FAMILY RISK MANAGEMENT FILE LISTS THE BELOW POTENTIAL CAUSE OF AN INFLAMMATORY REACTION: TOO SUPERFICIAL PLACEMENT OF THE SUTURES RESULTING IN INFLAMMATION. THE PATIENT HAS AN UNDERLYING MEDICAL CONDITION SUCH AS AN AUTOIMMUNE DISEASE. THE IFU STATES THAT PATIENT WITH AN ACTIVE, OR HISTORY OF AUTOIMMUNE DISEASE SHOULD NOT UNDERGO TREATMENT. A CHANGE IN THE PATIENT'S HEALTH STATUS POST TREATMENT, RESULTING IN A SERIOUS ADVERSE EVENT. PATIENT REACTION, WHERE THE PATIENT'S IMMUNOLOGICAL RESPONSE TRIGGERS AN ADVERSE EVENT. THE PATIENT HAS A HISTORY OF PREVIOUS AESTHETIC TREATMENTS/PROCEDURES AND EXPERIENCES A SECONDARY REACTION POST SILHOUETTE INSTALIFT TREATMENT. THE IFU STATES THAT ALTHOUGH THE COMBINATION USE OF SILHOUETTE WITH OTHER AESTHETIC PROCEDURES HAS BEEN REPORTED IN LITERATURE, THE SAFETY OF SUCH COMBINATION TREATMENTS HAS NOT BEEN FORMALLY ESTABLISHED. CONCLUSION: DUE TO THE LIMITED INFORMATION RECEIVED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    A PATIENT REPORTED HAVING UNDERGONE TREATMENT WITH SILHOUETTE INSTALIFT IN (B)(6) 2021 (NO FURTHER INFORMATION RECEIVED). ON AN UNSPECIFIED DATE, THE PATIENT REPORTED EXPERIENCING INFLAMMATION (NO FURTHER INFORMATION RECEIVED). THE PATIENT HAS REPORTED HAVING UNDERGONE SIX SURGERIES AND THAT FOLLOWING ASSESSMENT BY PHYSICIANS, THEY ARE OF THE OPINION THAT SHE IS NOT EXPERIENCING AN INFECTION (NO FURTHER INFORMATION RECEIVED). AS OF (B)(6) 2022, THE PATIENT IS CONTINUING TO EXPERIENCE SWELLING. SINCLAIR ARE FOLLOWING UP FOR FURTHER INFORMATION.

    Description of Event or Problem · 0

    DESPITE REQUESTS, SINCLAIR HAVE NOT RECEIVED ANY FURTHER INFORMATION REGARDING THE EVENT. NO PHOTOGRAPHIC CONFIRMATION OF THE SYMPTOMS WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629929 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O